When patients behave badly: Consent, breach of the duty of care and the law
Perspective
Anne‐Maree Kelly, Tina Cockburn, Bill Madden
Emergency Medicine Australasia, 2 December 2020
Abstract
Patients who are abusive or aggressive in ED raise special clinical and legal challenges. These include what steps clinicians should take to exclude serious illness/injury as the cause of the behaviour and when investigations or treatments can be imposed on these patients without their consent. Using a case illustration, this paper discusses legal issues which arise in this context, including how the standard of care owed by clinicians is determined and what may constitute a breach of duty; such patients’ right to consent to (or decline) tests and treatment; and when clinicians may lawfully act without consent and/or control the patient’s behaviour.

Informed Consent in Right-to Try – A Dubious Assumption
Rebecca Dresser
Wake Forest Journal of Law & Policy, 2020; 11(1)
Open Access
Excerpt
In the debate over right-to-try, everyone agrees that the patient’s informed consent is essential. If individual autonomy is the justification for giving patients access to experimental interventions, then adequate understanding must be part of the process. To make autonomous choices, patients must compare the potential harms and benefits of investigational drugs to their other medical options.
Is it possible for patients to make informed decisions in the right-to-try context? Will patients make autonomous decisions about trying investigational drugs when expert oversight is absent? Much of the critical commentary on right-to-try laws focuses on the damage the laws could do to other patients in need of safe and effective treatments.1 But these laws also present dangers to the patients who are their purported beneficiaries.2 Right-to-try supporters claim that patient autonomy underlies their crusade, but they have done little to ensure that patients actually understand the choices these laws allow them to make.
This article examines the deficiencies in right-to-try requirements for informed consent. Part I reviews right-to-try statutes, focusing on the federal right-to-try law that was adopted in 2018. This part also compares the informed consent provisions in right-to-try laws with informed consent provisions in two other laws authorizing patient access to experimental interventions: federal law governing participation in human subject research and the Food and Drug Administration’s (“FDA”) Expanded Access Program…

Clinicians’ consent law knowledge: The case for education
Denise Patricia Craig, Fintan Thompson
Focus on Health Professional Education, 2020; 21(3)
Abstract
Introduction
The short-term objectives of this study were to investigate clinicians’ confidence with, and knowledge of, consent laws, their behaviour regarding familiarisation with patients’ advance care plans and the potential benefit of brief education. Education covered patients’ rights to refuse treatment, including via advance directive, and the legislated hierarchy of decision-making authority.
Methods
Throughout 2018, all clinicians at one Queensland Hospital and Health Service were invited to attend a 1-hour legal education session. The study used a crosssectional survey to measure clinicians’ knowledge before and after education. Responses from 316 pre- and 319 post-education questionnaires were analysed.
Results
A 1-hour legal education session improved clinicians’ understanding of legislated consent hierarchy and patients’ rights. Pre education, 4.1% of participants correctly identified the lawful consent hierarchy, rising to 65.5% after education. Accuracy increased significantly after education; however, substantial errors persisted.
Conclusions
The potential benefit of education to increase multidisciplinary clinicians’ legal knowledge was supported. Education can ensure that clinicians are made aware of patients’ rights and the potential complexity of lawful substitute decision making.       

Problematizing consent: searching genetic genealogy databases for law enforcement purposes
Samuel, D. Kennett
New Genetics and Society, 18 November 2020
Abstract
Genetic genealogy databases have become particularly attractive to law enforcement agencies, especially in the United States (US), which have started to employ genealogists to search them with unknown origin DNA from unidentified human remains (suicides, missing persons) or from a serious crime scene, to help identify the victim, or a potential suspected perpetrator, respectively. While this investigative genetic genealogy (IGG) technique holds much promise, its use – particularly during serious criminal investigations – has sparked a range of social and ethical concerns. Receiving consent for IGG from genetic genealogy database users has been argued as a way to address such concerns. While critiques of the importance of consent are well documented in the biomedical and forensic biobanking literature, this has not been explored for IGG. We sought to address this gap by exploring the views of UK stakeholders. Our research question was: what are UK public and professional stakeholders’ views about the importance of the consent process for IGG when used for serious criminal cases? The methodological approach was interview-based and exploratory. Our analysis identified that all interviewees stressed the importance of consent, though interviewees’ narratives pointed to inadequacies of individual-based consent as an ethical panacea for IGG.

Legal issues in end-of-life care 2: consent and decision-making
Helen Taylor
Journal of Paramedic Practice, 9 November 2020; 12(11)
Abstract
Paramedics are legally and professionally obliged to uphold their patients’ right to dignity, respect and autonomy—and this includes the general requirement to obtain their consent before proceeding with any intervention. The first instalment of this two-part article considered the challenges that this might present to the paramedic. This second article develops this theme and further explores the legal framework underpinning the decision-making process when caring for a patient approaching the end of life. It also examines issues around consent and mental capacity in more depth and addresses matters such as such as advance decisions to refuse treatment (ADRT) and do not attempt cardio-pulmonary resuscitation (DNACPR) decisions.

Informed Consent and Health: A Global Analysis, Thierry Vansweevelt and Nicola Glover-Thomas (eds) [BOOK REVIEW]
Craig Purshouse
Medical Law Review, 28 October 2020
Excerpt
The English law of ‘informed consent’, which regulates what information doctors should provide to patients, has been influenced by, and influenced, other jurisdictions. In Sidaway v Bethlem Royal Hospital, Lord Scarman (in the minority) referred to the ‘transatlantic doctrine of informed consent’ and endorsed the prudent patient test as the determinant of information disclosure. The majority of the House of Lords, however, rejected the patient-friendly approach prevalent in the USA and Canada and, instead, adopted the Bolam standard of disclosure, whereby doctors would escape liability provided they complied with peer opinion regarding what information should be disclosed to patients. The High Court of Australia chose a different path…

Informed consent to clinical research in India: A private law remedy
Research Article
Himani Bhakuni
Medical Law International, 23 September 2020
Abstract
There is a well-established common law doctrine for ascertaining information disclosure in informed consent claims within the treatment context that governs the doctor–patient relationship. But there is no such doctrine in clinical research governing the researcher–participant relationship in India. India, however, is not exceptional in this regard. Common law countries like the United States and Canada at most have sparse, non-systematised, criteria for such cases; arguably, a doctrine for research is at its nascent stage. But the adequacy of the existing criteria for settling informed consent claims in research has hardly ever been discussed. Furthermore, a specific discussion on the applicability of this ‘nascent doctrine’ to India is non-existent. This article discusses both. The article examines case law from India and other common law jurisdictions that hint at developments in this area. It suggests that Indian courts need to move abreast with other jurisdictions to better protect India’s patients and research participants.

Informed consent, Montgomery and the duty to discuss alternative treatments in England and Australia
Research Article
Tracey Carver
Journal of Patient Safety and Risk Management, 9 September 2020
Abstract
The UK Supreme Court in Montgomery v Lanarkshire Health Board imposes a duty on healthcare professionals in relation to information disclosure. The obligation is to take reasonable care to ensure that patients are aware, not just of material risks inherent in any recommended treatment, but of any reasonable alternative treatments. While liability for information non-provision was previously decided according to whether the profession would deem disclosure appropriate, the law now judges the sufficiency of information from a patient’s perspective. In doing so, it adopts the approach advocated for Australia in Rogers v Whitaker. However, commentators, in this journal and elsewhere, have expressed concern that the disclosure obligation is unclear. Although Montgomery defines what is ‘material’ for the purpose of identifying notifiable treatment risks, it offers less guidance as to when alternative treatments will be sufficiently ‘reasonable’ to warrant disclosure. Through an analysis of Australian and UK case law and examples, this article considers the ambit of a practitioner’s duty to discuss alternatives. It concludes that although likely subject to further litigation, the identification of reasonable treatment options requiring disclosure will be influenced by the patient’s clinical condition, their prognosis and viable options from a medical perspective, and various non-clinical matters influenced by the test of materiality.

Contributory factors to the evolution of the concept and practice of informed consent in clinical research: A narrative review
Review Article
Lydia O’Sullivan, Rachel Crowley, Éilish McAuliffe, Peter Doran
Contemporary Clinical Trials Communications, 13 August 2020
Abstract
Informed consent can be defined as a freely-given decision or agreement following disclosure of relevant information. This review explores how legislation surrounding informed consent has impacted upon clinical research practices, with a focus on clinical trials involving individuals with the capacity to give consent in the non-emergency setting. We also highlight the challenges which remain with the informed consent process, including those which exist in the era of data protection legislation and genetic research.

Modern ethicists agree that informed consent encompasses three principal factors: disclosure of information, capacity for decision making, and voluntariness. In the context of clinical research, informed consent is now required by regulatory and ethical frameworks as well as by law, and various guidelines govern the practice of informed consent, including the Declaration of Helsinki and the Good Clinical Practice Guidelines. Historically, however, researchers acted paternalistically and, included participants in research without their knowledge or consent. Following societal and political revolution, an autonomy model of consent became prevalent, and individuals become free to make individual choices about whether to participate. Despite this, it is also recognized that an individual’s community has a role in supporting their decision making, and this may be a strong influence, particularly within some societies. Research scandals and controversies and whistle-blowers which exposed unethical practices in the area of informed consent also contributed to changes in societal attitudes and legislation changed as a result. Medical journals also have an established, although indirect, role in strengthening good practices surrounding informed consent.